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This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL2200 | Experimental | Investigational product, PL2200 |
|
| Aspirin tablets | Active Comparator | Active comparator, 325 mg aspirin tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PL2200 | Drug | PL2200, containing 325 mg aspirin active ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Gastroduodenal Ulcers | Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth | 42 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Erosion and Ulcers | >5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jupiter | Florida | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | PL2200 | Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient |
| FG001 | Aspirin Tablets | Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aspirin tablets | Drug | 325 mg aspirin tablets (USP) |
|
| South Miami |
| Florida |
| United States |
| Towson | Maryland | United States |
| New York | New York | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Chesapeake | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PL2200 | Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient |
| BG001 | Aspirin Tablets | Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Gastroduodenal Ulcers | Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth | Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant) | Posted | Number | participants | 42 Days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Erosion and Ulcers | >5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy | Full analysis set population, as randomized. Subjects treated with at least one dose of study drug and day 7 endoscopy | Posted | Count of Participants | Participants | 42 days |
|
|
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Safety Population: participants treated with ≥ 1 dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PL2200 | Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient | 0 | 121 | 60 | 121 | ||
| EG001 | Aspirin Tablets | Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP) | 0 | 126 | 68 | 126 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders |
| |||
| Gastric Ulcer | Gastrointestinal disorders |
| |||
| Oesophagitis | Gastrointestinal disorders |
| |||
| Headache | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs Director | PLxPharma | 17138421249 | regaffairs@plxpharma.com |
| ID | Term |
|---|---|
| C557598 | aspirin-phosphatidylcholine |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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